Navigation Links
Celtaxsys Begins US Enrollment for Phase 2 Trial of Acebilustat Anti-Inflammatory Therapy for Cystic Fibrosis
Date:10/8/2015

ATLANTA, Oct. 8, 2015 /PRNewswire/ -- Celtaxsys, a clinical stage drug development company focused on advancing care for patients suffering from orphan inflammatory diseases, announced today the commencement of the US arm of an international phase 2 clinical trial for its flagship compound, acebilustat, in patients with cystic fibrosis (CF). The study will be conducted at approximately 60 sites in the United States and European Union, with the EU sites anticipated to begin enrollment early 2016. This landmark clinical trial testing once-daily oral acebilustat treatment over 48 weeks could be the first to establish proof-of-concept for an anti-inflammatory treatment specifically designed to prevent long-term loss of lung function in CF patients. The study will test once daily oral doses of 50 mg and 100 mg acebilustat against placebo on top of background therapy in adult CF patients.

Acebilustat is a first-in-class neutrophil modulator that controls a key inflammatory signal overexpressed in CF and other orphan inflammatory diseases. Acebilustat has been granted orphan drug status for the treatment of CF in the US and the EU.  Results from initial clinical studies in CF patients demonstrated acebilustat's ability to moderate the over-activated inflammatory response in CF, decreasing neutrophils in the lung by 65% and decreasing damaging neutrophil elastase in just two weeks of treatment. Acebilustat did this without jeopardizing the patient's immune response to infection. Importantly, acebilustat treatment is applicable to all CF patients irrespective of their gene mutation and can be used on top of background therapy, including Kalydeco and Orkambi.

The Phase 2 CF trial was designed in conjunction with and supported by a grant from Cystic Fibrosis Foundation Therapies, Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation. It will include approximately 30 sites in the US under the oversight of Principal Investigator Dr. Stephen Rowe MD MSPH, Professor at the University of Alabama Birmingham School of Medicine, Director of the Cystic Fibrosis Transition Clinic, and Director of the CFFT Development Network Center for CFTR Detection. Said Dr. Rowe, "CF patients are in desperate need of efficacious and safe anti-inflammatory therapies to control progressive lung disease.  Evaluation of the long term effects of acebilustat is a very important step in that direction, given the favorable Phase 1b results in CF patients."

For more information, please visit http://clinicaltrials.gov/show/NCT02443688.

Logo - http://photos.prnewswire.com/prnh/20150605/221207LOGO


'/>"/>
SOURCE Celtaxsys, Inc.
Copyright©2015 PR Newswire.
All rights reserved

Related medicine technology :

1. Celtaxsys, Inc. Gains FDA Clearance for Landmark Phase 2 Trial of Anti-Inflammatory Treatment for Cystic Fibrosis (CF)
2. Celtaxsys Has Regulatory Clearance to Begin Phase 2 Trial of Oral CTX-4430 Anti-Inflammatory Therapy for Moderate to Severe Acne Vulgaris - Recruitment of Patients to Commence Immediately
3. Celtaxsys Announces Sanjeev Ahuja as Chief Medical Officer
4. Greg Duncan Appointed President and Chief Executive Officer of Celtaxsys, Inc.
5. Celtaxsys Announces Successful Completion of Phase 1 Clinical Trial for Development of CTX-4430
6. Celtaxsys Restructures, Enhances Operational Focus
7. Construction Begins at Genovate Biotechnologys Insulin Ecological Industrial Park in Chinas Changzhou National Hi-tech District
8. NOWDiagnostics Inc. Begins Manufacturing New Point-of-Care Tests Capable of Providing Results in Just Minutes with the Same Reliability as Lab-Based Tests
9. Worlds Most Technologically Advanced Cannabis Cultivation Facility And Laboratory Begins Operating In Delavan, Illinois
10. GSK begins shipping 2015-16 US flu vaccines with focus on customer needs, volume, and speed
11. Aethlon Medical Begins Trading on the Nasdaq Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/2/2017)... CaryRx, a next-generation full-service pharmacy, has announced the ... in the Washington D.C. metropolitan area. ... delivery of medications through the convenience of its patient-friendly mobile ... within one hour to any location in D.C. ... invaluable service to Washington D.C. ," says ...
(Date:7/28/2017)... Holdings, Inc. ("Hill-Rom") (NYSE: HRC), today announced financial results ... and updated its financial outlook for fiscal 2017. ... third quarter, Hill-Rom reported earnings of $0.09 per diluted ... prior-year period. These results reflect after-tax special items, including ... to the non-cash write-down of assets associated with the ...
(Date:7/26/2017)... Aesthetics, a leading medical aesthetic clinic in Singapore ... skin conditions from the inside. The natural process of ... skin becomes more transparent due to the thinning of the epidermis. Over ... the sun contributes to aging skin, causing age spots and other ... ...
Breaking Medicine Technology:
(Date:8/18/2017)... ... August 18, 2017 , ... Mediaplanet today ... for active, healthy lifestyles and highlighting the importance of proactive eye and ear ... and shares the latest innovations in hearing aid technology. , In this ...
(Date:8/18/2017)... ... August 18, 2017 , ... Radabaugh & ... assistance to communities in North-Central West Virginia, is embarking on a cooperative charity ... in the area. , The Chestnut Mountain Ranch (CMR) is a Christ-centered boarding ...
(Date:8/18/2017)... Humble, TX (PRWEB) , ... August 18, 2017 ... ... insurance management and financial planning firm that serves residential and commercial clients in ... a charity drive to raise community support for the fight against cancer. , ...
(Date:8/18/2017)... ... ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh in Abilene, Texas, has released ... pertaining to the mother of the Savior whom the world calls “Mother Mary”. Yisrayl says ... the role of this historical woman. , “The world bows, kisses the feet of, ...
(Date:8/18/2017)... ... , ... “Our Mountains to Climb: A Journey of Love and Faith Through ... through the faith they shared to overcome struggles in life. “Our Mountains to Climb: ... Barbara J. Corcoran, a retired teacher and happily married since 1999; the author’s personal ...
Breaking Medicine News(10 mins):